Anchor Sleeve Deployment Tool for Secure Medical Device Anchoring
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Solution Overview
Problem
Existing methods for deploying anchor sleeves on implantable medical devices, such as drug delivery catheters and medical electrical leads, face challenges in securely anchoring these devices to subcutaneous fascia, particularly in providing a snug and reliable fit to facilitate effective anchoring.
Innovation Solution
The introduction of an introducer assembly comprising a flexible polymer or metal introducer shaft with a tapered distal tip and a deployment tool that allows for the precise placement and deployment of an anchor sleeve around the medical device, utilizing a lubricious interface and retaining features to ensure secure anchoring without leaving the deployment tool behind.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an anchor sleeve is deployed using a deployment tool, then the anchor sleeve can be positioned around the device body, but the deployment tool may be inadvertently left behind in the patient's body
Solution Approach 1:
The deployment tool is designed with a breakable feature that allows it to be intentionally broken and discarded in a controlled manner after deployment, preventing accidental retention while ensuring complete removal of functional components
Solution Approach 2:
The functional deployment features are extracted from the main tool body and placed on a separable distal portion that can be removed or broken off after use, leaving only inert material in the body
2Difficulty of detecting and measuring
If the distal portion of the deployment tool is made radiopaque for visibility, then the tool can be tracked during implantation, but the radiopaque material may complicate removal or indicate incomplete removal
Solution Approach 1:
The deployment tool is divided into radiopaque and radiolucent segments, allowing the proximal handle to be visible for tracking while the distal deployment portion becomes radiolucent after breaking off, enabling clear distinction between retained functional material and inert retained material
Solution Approach 2:
The tool uses radiographic 'color' changes (radiopaque to radiolucent) to indicate different functional states and removal status, where radiopaque material indicates active tool components and radiolucent material indicates inert retained portions
3Ease of operation
If the deployment tool is designed to be broken in half for removal, then the tool can be removed in segments, but the break point must be precisely controlled to avoid leaving functional components behind
Solution Approach 1:
A pre-formed fracture feature is created during manufacturing at the exact location where breaking is needed, eliminating the need for precise control during the breaking operation itself and ensuring consistent separation points
Solution Approach 2:
The distal portion of the deployment tool is designed as a disposable component that is intentionally broken off and left in the body after deployment, eliminating the need for complete tool removal and simplifying the removal process
Data Source
AI summary
An introducer assembly that may be employed to implant a medical device includes an introducer shaft, and an anchor sleeve and a deployment tool mounted on the shaft. According to some methods, the sleeve is deployed onto an elongate body of the medical device, after the body has been advanced through a lumen of the introducer shaft and to an implant site within a body of a patient, by pulling the introducer shaft proximally, out from the body of the patient, while holding the deployment tool in place, relative to the advanced body of the device.